Functional neurological disorder (FND) Nervous System Diseases
Conditions
Interventions
Current interventions as of 01/04/2025:
Participants will be randomised on a 1:1 basis using an online randomisation tool to either the somatic yoga programme (active) or to a music relaxation progr
Sponsors
King's College London
Eligibility
Sex/Gender
All
Age
18 Years to 120 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18 years or older 2. Normal or corrected eyesight 3. Fluency in English language 4. A primary diagnosis of FND* with motor symptoms, seizures, sensory symptoms or mixed symptoms *FND diagnosis will be validated by asking the participants to provide proof of diagnosis in the form of an existing medical letter from a qualified healthcare professional
Exclusion criteria
Exclusion criteria: 1. Comorbid diagnosis of major cardiovascular (e.g., heart disease), psychiatric (e.g., active psychosis, severe alcohol or substance use disorder) or neurological (e.g., epilepsy, multiple sclerosis) disorder that would either confound the findings or impair the participant’s ability to participate 2. Physical symptoms/disability impairing ability to perform tasks or attend the in-person therapy sessions (e.g., severe tremor, upper/lower limb paralysis, seizure frequency >10 per day) 3. Functional cognitive symptoms only 4. Currently undergoing another body-based intervention for FND* *Participants already engaging in body-based (e.g., yoga, acupuncture) or music-based therapies (self- or therapist-guided) will be asked to abstain from these sessions during this study. If unfeasible, participants will be excluded from the current study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Feasibility: 1. Recruitment: The number/proportion of eligible participants who consent to participate in the study by 30/06/2025 2. Adherence: The number/proportion of scheduled intervention sessions attended and completed 3. Withdrawal: The number/proportion of enrolled (consented) participants who withdraw from the study prior to completion 4. Adverse events: The number and nature of adverse events reported during study participation 5. Acceptability: Qualitative measures of perceived benefit of intervention, barriers and facilitating factors, experiences of study procedures | — |
Secondary
| Measure | Time frame |
|---|---|
| Current secondary outcome measures as of 01/04/2025: Assessed at the start, middle and end of the intervention (weeks 1, 3 and 6) and at 3-month follow-up: 1. FND symptom severity measured using the Clinical Global Impression-Improvement Scale; Functional Neurological Symptom Questionnaire 2. Physical symptoms measured using the Patient Health Questionnaire – 15; Somatoform Dissociation Questionnaire – 20 3. Psychological symptoms measured using the Patient Health Questionnaire – 8; Generalized Anxiety Disorder – 7; Multiscale Dissociation Inventory; Positive & Negative Affect Schedule; Clinician Administered Dissociative States Scale 4. Health-related quality-of-life measured using the 36-item Short Form survey 5. General functioning measured using the Work & Social Adjustment Scale 6. Autonomic symptoms measured using the Body Perception Questionnaire-Short Form 7. Interoceptive awareness measured using the Multidimensional Assessment of Interoceptive Awareness 8. Emotional processing measured using the Toronto Alexithymia Scale – 20 9. Interoceptive accuracy measured using the modified Schandry heartbeat tracking task Measured at the start and end of the intervention (weeks 1 and 6-8): 10. Autonomic activation measured using electrocardiography; electrodermal activity recording 11. Emotion regulation measured using the computerised affective images task 12. Cognitive control measured using CANTAB Connect automated tests _____ Previous secondary outcome measures: Assessed at the start and end of the intervention (weeks 1 and 6): 1. FND symptom severity measured using the Clinical Global Impression-Improvement Scale; Functional Neurological Symptom Questionnaire 2. Physical symptoms measured using the Patient Health Questionnaire – 15; Somatoform Dissociation Questionnaire – 20 3. Psychological symptoms measured using the Patient Health Questionnaire – 8; Generalized Anxiety Disorder – 7; Multiscale Dissociation Inventory; Positive & Negative Affect Schedule | — |
Countries
England, United Kingdom
Contacts
Public ContactSusannah Pick
Outcome results
None listed